Access to hepatitis C treatments is increasing, so are therapeutic options, but most of those living with the disease are not diagnosed and thus remain untreated, the World Health Organization found in a new report. Upper-middle income and high-income countries continue to pay high prices, impeding equitable access, and those countries which have been most successful in increasing access have mobilised a strong government response, the report found.

The World Health Organization in the past week published its second progress report on access to hepatitis C treatment. The report focuses on overcoming barriers in low-and middle-income countries.

According to the report, access to “highly effective direct-acting antivirals” (DAA) for the treatment of hepatitis C is increasing and has the potential to end hepatitis C virus (HCV) epidemics. However, a small number of countries are responsible for the bulk of that increase. Egypt and Pakistan accounted for about half of all people who started treatment in 2016, the report says, though it underlined progress in countries such as Australia, Brazil, China, France, Georgia, Mongolia, Morocco, Rwanda and Spain.

Increased competition from generic manufacturers since 2015 has led to steep price reductions, but some 60 percent of people with HCV infection now live in countries that could procure more affordable generic treatments, the report notes.

Prices in upper-middle income and high-income countries remain high, however, impeding equitable access to safe and effective treatment, the report underlines. Those countries, such as Brazil, China, Colombia, Mexico and Turkey, are typically not included in licence agreements and represent 38 percent of people living with HCV globally. it says.

“Countries that try to negotiate reduced prices with manufacturers require market intelligence on what other countries and buyers are paying,” the report says. It includes updated information on DAA prices and registration collected from “a selection” of countries, and a summary of procurement data.

The report also found that the majority of the estimated 71 million people living with HCV remain untreated, mostly because they are not diagnosed. Globally, it says, only about one in five people living with HCV in 2016 had been diagnosed, and in low-income countries, less than 10 percent of people infected with HCV had been diagnosed. Some 40 percent are diagnosed in high-income countries, says the report.

The WHO analysed country experiences in the treatment of HCV, and found that while access to affordable treatment is key, countries need a strong government response, national plans for preventing. diagnosing and treating HCV, and adequate financing.

The report explains that treatment expansion has been most successful in countries that have mobilised a strong government response, such as in Australia, Brazil, Egypt and Mongolia.

According to the report, financing should increase in most countries, and should come from domestic sources as part of a broader push toward universal health coverage.

“Unlike for the HIV, tuberculosis or malaria, international solidarity is still largely lacking in the viral hepatitis response,” the report found.

Treatment options for hepatitis C have increased and improved, with eleven DAA regimens which have received regulatory approval from “at least one stringent regulatory authority since 2013,” it says. The report suggests that originator and generic manufacturers seek WHO prequalification for their HCV products so countries can procure from a range of quality-assured diagnostic and treatment options.

As of February 2018, WHO had prequalified the sofosbuvir tablets (Gilead) from three generic companies as well as daclatasvir tablets (Bristol-Myers Squibb) of the originator company. However, the report points out, the majority of generic DDAs are neither WHO-prequalified nor authorised by a “stringent regulatory authority.”

The report also underlines WHO’s efforts to support the scaling up of hepatitis C treatments. For example, WHO assists in drafting and implementing national testing and treatment policies, and has edited a “WHO Manual for the development and assessment of national viral hepatitis plans: a provisional document.”

WHO provides technical assistance for scaling up treatment and addressing price and intellectual property-related barriers, the report says. WHO also documents the status of the HCV response, trends in access to and use of DDAs, and new developments related to prices, registration, intellectual property rights and procurement of DAAs.

Comments

Importance in Upholding Intellectual Property Rights
Look at the Singapore and South Korea which we were once ahead in terms of economic growth including football for the latter. They are now way ahead of us in science, technology, innovation and in particularly biopharmaceuticals – Biopolis (Singapore) attracting Pfizer, Novartis, Sanofi, Abbvie and Amgen in investing their world class manufacturing plant and in the case of South Korea, biosimilar and generic companies like Celltrion Healthcare, Samsung BioLogics and Green Cross have their own R&D to develop products from scratch.

“What they had in common other than a good infrastructure is a pro-business environment which includes respecting IP Laws which in turn protects the inventors’ rights (aka moral rights) encouraging homegrown talents. In short, would you welcome a stranger to walk into your home and take away your property? If this happen, would you continue to buy a property in this country?”

Learning from 2003 Anti-retrovirals (ARVs) Compulsory Licensing (CL) –
The Healthcare Infrastructure was set up before exploiting CL. It took us a total of 17 years from the 1st HIV case was diagnosed in Malaysia (1986) before the Malaysian government has agreed to take the bold decision to issue a Compulsory Use Licensing under the TRIPS Flexibilities and at that point of time, our national registry registered 53,000 patients versus of what we have today of 20,023 patients living with Hepatitis C (the total number of people living with HCV between 2003-2016 as reported by the YAB Minister of Health in March 14, 2017), taking us 27 years from the first published data on Hep C prevalence (Raihan R., 2016) to decide we have a public health problem with Hep C! Looking back, with a handful of Infectious Diseases Physicians (probably less than 15 ID Physicians versus 170 gastroenterologists and hepatologists of today’s) our international renown leaders in the field of HIV like Datuk Dr Christopher Lee, Prof Dr Adeeba Kamarulzaman, Tan Sri Dr Ismail Merican and Datuk Dr Sha’ari Ngadiman had played an instrumental role in driving patients access to ARVs through a mix of initiatives that brought MOH, MOHE and 7 NGOs together and with one goal – Patients Access to ARVs (to read more on Malaysia AIDS/HIV Fact, please visit https://www.unicef.org/malaysia/Factsheet-AIDS-Timeline-Malaysia-and-Global.pdf).

A pre-execution plan summing to a total of 11 years of hardships coming from different ministries, clinicians and NGOs such as Malaysian Aids Council. The government of Malaysia has firstly set up an inter-ministerial committee to be function as an advisor to the cabinet on the policies, issues and strategies related to AIDS/HIV, prior the implementation, the MOH has put in place a robust detection and prevention program (e.g. PMCT, Prevention Mother Child Transmission in 1998, an infrastructure to support treatment when it is widely available e.g. Primary Health Care Centres in 2000 involving 30 clinics, Harm Reduction Program and etc.)

Government Use Licensing (GUL) Disconnects Us All:

The recent GUL for HCV treatment, has not only disconnect the Ministry Of Health and Ministry of Higher Education further (since GST implementation MOHE has been looked at differently by the MOH although both are seeing the same diseases and patients type) but it has also disconnected with the Ministry of Finance, Ministry of International Trade and Industry and Ministry of Domestic Trade, Cooperatives and Consumerism from a country’s economic health perspective and more worrisome as it further dampened our thrust in Exporting Malaysian Made Products (e.g. our Patent Protected AI-enabled stethoscope which was FDA approved), Foreign Direct Investment and Country’s Trust and Openness Score, which may lead to risking Malaysia to be enlisted in the 301 Watch List:

Differing views of the country’s economic health for instance, on one hand we are announcing to the world that we are on track in moving towards a high income nation status, but depending on low middle income countries for the supply of generics
Declining the use of Voluntary Licensing offered by Gilead Sciences goes with some loss opportunity costs associated with prolonging the time to start treatment for some of the critically ill patients with the readily available treatments registered in Malaysia (both sofosbuvir and the single tablet regime sofosbuvir/ledipasvir have most patients with various degree of liver functionality being studied in the Landmark clinical trials), losing out price-volume negotiation power with the WHO Pre-Qualified licensed generic makers (as the bulk of the patients treatment volume would have come from MOH Hospitals), losing the opportunity to be one of the first within Asian countries to use the newest ARV tablet as HIV medicines were also offered as part of the Voluntary Licensing and loss of opportunity for the knowledge and technology transfer for one of the manufacturing process which is required to be performed by a highly skilled worker (this process forms part of the Patent Claims) and this would have helped to up-skill our local pharmaceutical manufacturing to stay competent and competitive, and delivering a higher Gross National Income Per Capita (Economic Transformation Plan) – translating to a step closer for Malaysia to reach the High Income Nation status.
Administering the Provisional Measures Set Forth in the TRIPS Agreement. Just to be clear, there is nothing wrong of Malaysian government decision to use GUL if both parties has shown reasonable efforts in attempting to engage and to develop a win-win strategy in pursuing patients access while preserving our country’s economic health and growth, as a precedence has been set in 2003 for antivirals used to treat patients living with HIV. Neither I am suggesting that there is any element or evidence associated or directing towards the voids in following the TRIPS procedures.

As a high middle income developing country that is striving to reach our international status of developed country, we need to start by acting as one – a suggestion would be exploring opportunities and leveraging our current economic position and playing the financial instruments that are available to us and to our economic advantage while achieving market access goals: Leveraging medical tourism to explore a private and government collaboration program that every Hep C Tourist treatment charged at a higher cost for tourists and a slight private mark up fees for Malaysian seeking treatment in private institutions (like a National Service Program for doctors practising in the Private Sector), with the gains to be subsidised back to the government Hep C Program through stocks. This and along with a Voluntarily Licensing Program from the originator will not only help MOH to achieve a self-sustainable Hep C Program that benefits Malaysians but also puts the country’s into a new light and positioning ourselves being creative and ever ready for TPPA or RCEP implementation.

Compulsory licensing and government use without the authorization of the right holder are allowed, but are made subject to conditions aimed at protecting the legitimate interests of the right holder. The conditions are mainly contained in Article 31. These include the obligation, as a general rule, to grant such licences only if an unsuccessful attempt has been made to acquire a voluntary licence on reasonable terms and conditions within a reasonable period of time; the requirement to pay adequate remuneration in the circumstances of each case, taking into account the economic value of the licence; and a requirement that decisions be subject to judicial or other independent review by a distinct higher authority. Certain of these conditions are relaxed where compulsory licences are employed to remedy practices that have been established as anticompetitive by a legal process. These conditions should be read together with the related provisions of Article 27.1, which require that patent rights shall be enjoyable without discrimination as to the field of technology, and whether products are imported or locally produced.
Adapted from the TRIPS Agreement, https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm#patents

Non-Coherence in National Policies may predispose us to risk the current income derived from Malaysian Pharmaceutical Industry. Malaysia takes pride in the growth of the pharmaceutical industry over the last decade. On one hand we are driving clinical research as an income source while the other action is in the opposite. We pride ourselves to have a good clinical trial infrastructures and centres that are linked to more than 50 general and district hospitals, and more than 100 health clinics as potential sites for clinical trials with access to 550 clinical investigators and 17 million patients from diverse therapeutic areas in the public health care system in Malaysia. 60% of the industry turnover dependent on imported pharmaceuticals through Multi-National Companies, contributing to Malaysia GDP through an average corporate income tax of 27% (translating it into approximately of RM 1.2 Billion of Government income) and not forgetting our Top 5 export destinations in 2016 were the Singapore (RM194 million), USA (RM155 million), Brunei (RM120 million), Indonesia (RM94 million) and Hong Kong (RM91 million).

DNDi’s HCV programme is partnering with access-oriented pharmaceutical companies, middle-income countries and other treatment providers to implement a strategy based on three mutually reinforcing pillars – first, accelerating the delivery of such a treatment, through the development of promising drug candidates in the pipeline; second, supporting policy change and political will to increase access to affordable treatment, for example by overcoming intellectual property (IP) and regulatory barriers; and third, working with health providers to develop simpler and innovative models of care, needed to support scale up of treatment to the millions still waiting.
As policymakers with public responsibilities, Ministry of Health must never forget that decisions taken in one sphere affect conditions, stakeholders and policies in another. We all want better health systems, but the impact of health on the economy should not be underestimated. Our challenge is to harmonise health and economic policies to improve health outcomes, of course, but also to minimise any negative impacts while promoting synergies wherever possible.

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